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临床试验/NCT00139919
NCT00139919已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study

Solvay Pharmaceuticals1 个研究点 分布在 1 个国家开始时间: 2006年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
试验地点
1

研究概览

简要总结

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
  • •Age 18 to 55
  • •Body weight 100-250 lbs
  • •Be sufficiently stable to allow discontinuation of antipsychotic medication

排除标准

  • •Acutely psychotic subjects
  • •Subjects that are acutely manic
  • •Subjects with a psych diagnosis other than Bipolar Type I Disorder

研究者

申办方类型
Industry

研究点 (1)

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